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BRIEF TITLE: STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06939999 (PRMT5 INHIBITOR) IN PARTICIPANTS WITH ADVANCED OR METASTATIC BLADDER CANCER

A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06939999 (PRMT5 INHIBITOR) IN PARTICIPANTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER, HEAD AND NECK SQUAMOUS CELL CARCINOMA, ESOPHAGEAL CANCER, ENDOMETRIAL CANCER, CERVICAL CANCER AND BLADDER CANCER


  • Org Study ID: C3851001
  • Secondary ID:
  • NCT ID: NCT03854227
  • NCT Alias:
  • Sponsor: Pfizer - Industry
  • Source: Pfizer

Brief Summary

This is a Phase 1, open label, multi center, dose escalation and expansion, safety, tolerability, PK, and pharmacodynamics study of PF 06939999 in previously treated patients with advanced or metastatic cancer.

Overal Status Start Date Phase Study Type
Recruiting March 14, 2019 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Number of participants with dose limiting toxicities (DLTs)

Primary Outcome 1 - Time Frame: Baseline through day 28

Primary Outcome 2 - Measure: Number of participants with treatment emergent adverse events (AEs)

Primary Outcome 2 - Time Frame: Baseline through up to 2 years or until disease progression

Primary Outcome 3 - Measure: Number of participants with laboratory abnormalities

Primary Outcome 3 - Time Frame: Baseline through up to 2 years or until disease progression

Primary Outcome 4 - Measure: Objective Response Rate

Primary Outcome 4 - Time Frame: Baseline through up to 2 years or until disease progression

Condition:

  • Advanced Solid Tumors
  • Metastatic Solid Tumors

Eligibility

Criteria:
Inclusion Criteria:

- Histologically or cytologically confirmed locally advanced or metastatic NSCLC,
urothelial carcinoma or HNSCC

- Progressed after at least 1 line of treatment and no more than 3 lines of treatment

- At least one measurable lesion as defined by RECIST version 1.1

- ECOG Performance Status 0 or 1

- Adequate Bone Marrow Function

- Adequate Renal Function

- Adequate Liver Function

- Resolved acute effects of any prior therapy

Exclusion Criteria:

- Known active uncontrolled or symptomatic CNS metastases.

- Major surgery, radiation therapy, systemic anti-cancer therapy or investigational
drug(s) within 4 weeks prior to study entry.

- Active, uncontrolled infection, including COVID-19

- Known or suspected hypersensitivity to PF-06939999

- Inability to consume or absorb study drug
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Pfizer CT.gov Call Center

Role: Study Director

Affiliation: Pfizer

Overall Contact

Name: Pfizer CT.gov Call Center

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Link: To obtain contact information for a study center near you, click here.

Locations

Facility Status Contact
Scottsdale Healthcare Hospitals d/b/a HonorHealth
Scottsdale, Arizona 85258
United States
Recruiting
Virginia G. Piper Cancer Pharmacy
Scottsdale, Arizona 85258
United States
Recruiting
Keck Hospital of USC
Los Angeles, California 90033
United States
Recruiting
LAC + USC Medical Center
Los Angeles, California 90033
United States
Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Recruiting
Keck Medical Center of USC Pasadena
Pasadena, California 91105
United States
Recruiting
AdventHealth Medical Group Oncology Research at Celebration
Celebration, Florida 34747
United States
Recruiting
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida 33021
United States
Not yet recruiting
University Of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center
Miami, Florida 33136
United States
Recruiting
AdventHealth Hematology and Oncology
Orlando, Florida 32804
United States
Recruiting
AdventHealth Orlando - Investigational Drug Services
Orlando, Florida 32804
United States
Recruiting
AdventHealth Orlando Infusion Center
Orlando, Florida 32804
United States
Recruiting
Memorial Cancer Institute at Memorial Hospital West
Pembroke Pines, Florida 33028
United States
Not yet recruiting
Norton Cancer Institute - Downtown
Louisville, Kentucky 40202
United States
Not yet recruiting
Norton Cancer Institute Downtown
Louisville, Kentucky 40202
United States
Not yet recruiting
Norton Hospital
Louisville, Kentucky 40202
United States
Not yet recruiting
St. Joseph Mercy Hospital
Ann Arbor, Michigan 48106
United States
Not yet recruiting
St. Joseph Mercy Brighton
Brighton, Michigan 48114
United States
Not yet recruiting
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan 48183
United States
Not yet recruiting
Henry Ford Medical Center-Fairlane
Dearborn, Michigan 48126
United States
Not yet recruiting
Henry Ford Hospital
Detroit, Michigan 48202
United States
Not yet recruiting
Henry Ford Medical Center - Columbus
Novi, Michigan 48377
United States
Not yet recruiting
Siteman Cancer Center - West County
Creve Coeur, Missouri 63141
United States
Not yet recruiting
Siteman Cancer Center-North County
Florissant, Missouri 63031
United States
Not yet recruiting
Barnes-Jewish Hospital
Saint Louis, Missouri 63110
United States
Not yet recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
United States
Not yet recruiting
Siteman Cancer Center - South County
Saint Louis, Missouri 63129
United States
Not yet recruiting
Siteman Cancer Center- St. Peters
Saint Peters, Missouri 63376
United States
Not yet recruiting
Prisma-Health Institute for Translational Oncology Research
Greenville, South Carolina 29605
United States
Not yet recruiting
Henry-Joyce Cancer Clinic
Nashville, Tennessee 37232
United States
Recruiting
Oncology IDS Pharmacy
Nashville, Tennessee 37232
United States
Recruiting
The University of Texas
Houston, Texas 77030
United States
Recruiting
NEXT Oncology
San Antonio, Texas 78229
United States
Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia 22031
United States
Active, not recruiting
Seattle Cancer Care Alliance
Seattle, Washington 98109
United States
Recruiting
University of Washington Medical Center
Seattle, Washington 98195
United States
Recruiting